FDA 510(k) Application Details - K180601

Device Classification Name	X-Ray, Tomography, Computed, Dental   More FDA Info for this Device
510(K) Number	K180601
Device Name	X-Ray, Tomography, Computed, Dental
Applicant	Villa Sistemi Medicali S.p.A. via delle Azalee 3 Buccinasco I-20090 IT Other 510(k) Applications for this Company
Contact	Paolo Casagrande Santin Other 510(k) Applications for this Contact
Regulation Number	892.1750   More FDA Info for this Regulation Number
Classification Product Code	OAS Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	03/07/2018
Decision Date	11/02/2018
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	RA - Radiology
Review Advisory Committee	RA - Radiology
Statement / Summary / Purged Status	Summary
Type	Abbreviated
Reviewed By Third Party	N
Expedited Review